1. Field of the Invention
The present invention generally relates to an improved composition for treatment of a skin condition. More specifically, the present invention relates to an improved composition for treatment for common types of skin ulcers, including diabetic, stasis, and decubitus ulcers.
2. Background Information
Various treatments for ulcer-type skin conditions are known in the art. More specifically, skin ulcer treatment regimens heretofore devised and utilized are known to consist basically of familiar, expected and obvious structural configurations, notwithstanding the designs encompassed by the prior art which have been developed for the fulfillment of various objectives and requirements.
Known documents include: U.S. Pat. No. 6,569,840, which relies on modified (oxidized) heparins; and U.S. Pat. No. 5,789,439, which relies one pharmaceutical use of forskolin derivatives.
While these treatments may fulfill their respective, particularly claimed objectives and requirements, the aforementioned documents do not disclose an improved composition for treating skin ulcers such as Applicant's present invention.
Today's society, particularly in the United States, is increasingly susceptible to Diabetes. In fact, the incidence of diabetes is rising precipitously. Genetic traits, in combination with poor diet and lack of exercise, are thought to be significant factors in one's likelihood of coming down with diabetes.
Type II diabetes is the most common form of the disease and accounts for 90 to 95 percent of all diabetes. Throughout the world, the incidence of Type II diabetes is nearing epidemic proportions. Examination of current and expected diabetic trends (and the detrimental effects therefrom) is helpful for grasping the tremendous need for the present invention.
By way of example, the Center for Disease Control and Prevention (“CDC”) reports an increase in the cases of diagnosed adult diabetes of 49% between 1990 and 2000. Further, the CDC estimates the diabetes, both diagnosed and undiagnosed, affects approximately seventeen million Americans (or some 6.2% of the U.S. population).
Diabetes is a prevalent disease and an ever-growing domestic and international public health concern. The World Health organization estimates that approximately 150 million people are affected by diabetes; and, these numbers are expected to only get worse (estimated 215 million people affected by 2010; estimated 300 million people affected by 2025). Worldwide, diabetes has a relatively high mortality rate. Diabetes is reportedly among the top five causes of death by disease in most countries, though this may be a conservative ranking. More likely, diabetes is even more deadly as it is frequently under reported on death certificates. Finally, diabetes does not discriminate. Similar trends in the increase incidence of diabetes has been observed across both sexes, virtually every age group, different ethic groups, all socio-economic backgrounds, and every state in the Union. Importantly, the occurrence of diabetes and skin ulcers is directly related. Accordingly, the sharp increase in the number of people having diabetes has led to an increase in the number of people affected by skin ulcers. By way of example, diabetics have a fifteen percent chance of developing a foot ulcer during their lifetime. Of those diabetics that develop foot ulcers, approximately twenty percent will require amputation. (International J of Pharm Compounding 8(4) July/August 2004, 269). Such amputations are also increasing at an alarming rate. Between 1990 and 2000, the number of amputations resulting from foot ulcers increased by twenty six percent. This trend is expected not only to continue, but to worsen in the coming years. Foot ulcers cause approximately eighty five percent of all diabetic amputation of the lower extremities (Emergency Medicine 36(8) Au 2004, 14-23). The number of such lower extremity amputations (LEA's) now exceeds 100,000 per year!
Recurring foot ulcers, and the amputations that may result, present a continuing problem on a national and global scale. In the event that an ulcer is successfully treated, it is more likely than not that the ulcer will reoccur. Recurrence rates associated with diabetic foot ulcers and resulting LEA's are commonly as high as fifty percent to seventy percent over a period of three to five years.
Those skilled in the art of ulcer treatment realize that the accepted standard of care is simply not working. Current medications s of treatment all too commonly fail to heal ulcers and prevent the occurrence of complications such as infection and gangrene. Overall, fifty to eighty percent of patients having diabetic foot ulcers will heal within six months, assuming optimal management from a multi-disciplinary team. (Emergency Medicine 36(8) August, 2004, 14-23). However, all too common complications require hospitalization, painful and expensive surgery, and a prolonged rehabilitation regimen. With the incidence of ulcer recurrence as high as seventy percent, the healing of one ulcer is often rapidly followed by the development of a new one.
In view of the serious consequences of diabetic ulcers and the utter inability to effectively treat those ulcers, a great need exists for an improved treatment. Applicant's invention, through a novel composition and associated methods of applying that composition, provides a much needed solution to the problems mentioned above. While known regimens rely on the use of debridement and washing, the present invention does away with this accepted treatment. Applicant has found that such treatment typically results in scarring, non-closure of the wound, and/or recurrence. Instead, the present invention relies on a novel combination of ingredients that is particularly effective in increasing blood flow and nerve growth about the wound.
A few practical examples, experienced first hand by Applicant, shed light on the startling results associated with the present invention:
Patient B has had diabetes for several years, the last two of which he has been confined to a wheel chair. During this past year Patient B has been hospitalized for non-healing pressure ulcers on his buttock region. Every developed ulcer has caused a tremendous amount of pain an suffering. Also, these ulcers have necessitated surgery and costly medical bills. Complication of these ulcers extended to the pelvic bone, which required removal of a portion of the bone. The present composition was applied to the wound one time per day for a period of three days. By the third day of treatment the wound had decreased in size by approximately twenty five percent. Also, the wound was radically improved, where approximately thirty percent of the wound had been covered with new white granular tissue with obvious healing occurring throughout the entire ulcer. During the next three days, the composition was applied twice daily. After a total of six days of treatment, the original wound was virtually covered with new tissue growth.
Before application of the present composition, Patient F had lost one finger tip to an ulcer and poor circulation. Her entire hand was rigid and swollen. Before treatment, several of Patient F's fingers were at risk of amputation. After a week of application of the present composition, her hand was soft and mobile, had better circulation, less pain, and a reduction of dark areas marked by poor blood flow. A single lesion had been open to the bone; however, after three days of treatment the lesion went from oozing blood and pus to being completely closed. According to standard treatment protocols, Patient F's lesion would have been reopened for further drainage. However, the present regimens avoids such a necessity.
Patient F has an open scalp lesion of approximately two centimeters in length. After three days of treatment (where the patient continued to wash the wound against Applicant's advise), the lesion had decreased by seventy percent. From the fourth to sixth day, the patient did not wash the wound. By the night of the forth day the lesion has completely closed, By day six, the patient reported a fifty percent reduction in pain such that she could rest her head upon a pillow to sleep.
Patient K had a developing lesion between her buttocks, which appeared to have a monilial infection. Applicant fear the overlying yeast infection would block entry of the present composition. After two days of treatment, the lesion had improved by some fifty percent. After a week of treatment, the lesion had completely healed and the patient reported a tremendous decrease in pain and overall discomfort.